Clinical Trial: A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

Detailed Summary:

  • Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
  • All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
  • Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
  • All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
  • Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
  • Measures to assess effectiveness and safety will be conducted at all follow-ups.
  • Safety will be assessed by the collection of adverse events at all timepoints.

Sponsor: Geistlich Pharma AG

Current Primary Outcome:

  • Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years [ Time Frame: 2 years post-surgery ]
    The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
  • MRI (magnetic resonance imaging) assessment of structural repair parameters. [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]
    Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System. [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]
    The Change from Baseline will be evaluated.
  • Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS). [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]
    The Change from Baseline will be evaluated.
  • Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package". [ Time Frame: 6 months and 1,2 and 5 years post-surgery ]
    The Change from Baseline will be evaluated.
  • Adverse Events (AE) Review [ Time Frame: 5 years post-surgery ]
    The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.


Original Secondary Outcome: Same as current

Information By: Geistlich Pharma AG

Dates:
Date Received: December 2, 2016
Date Started: December 2003
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017